Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction (AvBSR)

Axillary Versus Primary Breast Approach for Second-stage Operation in Expander-Implant Breast Reconstruction

The goal of this clinical trial is to compare the safety of axillary or primary breast approach for second-stage operation in expander-implant breast reconstruction for breast cancer patients. The main question it aims to answer are: 1. if the wound related events, including wound dehiscence, infection, delayed healing is significant less often in patients receiving second stage operation via axillary approach compared with primary breast approach; 2. if the aesthetic outcome is comparable between patients receiving different approach for second stage operation. To answer these questions, the breast cancer patients have received nipple-sparing or skin-sparing mastectomy and had breast tissue expander insertion via breast incision, will be prospectively recruited, and randomized into two groups while receiving implant exchange operation: (1) operate via axillary incision; (2) operate via primary breast incision.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Neoplasm Female; Breast Reconstruction; Wound Complication
• Intervention / Treatment: Procedure: implant exchange operation

• Study Type: Interventional
• Enrollment (Anticipated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chao NI; Phone Number: +8613989463951; Email: nicaho428@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age 18 + (inclusive)
• Female
• Invasive breast cancer or ductal carcinoma in situ was confirmed by preoperative pathology
• SSM/NSM (skin sparing/nipple and areola sparing mastectomy) combined with expander implantation has been performed within a year
• An incision on the surface of the breast is used to place an expander in the first-stage surgery
• There is no clinical or radiological evidence of distant metastasis
• Expander removal combined with prosthesis implantation is planned
• Able and willing to sign an informed consent

Exclusion Criteria:

• The first SSM/NSM combined expander implantation was performed via axillary approach
• Patients participate in other clinical trial, which could potentially affect their participation in this trial
• Adjuvant radiotherapy was planned post-operation
• Patient who is pregnant and lactating
• The expander is not sufficiently expanded pre-surgery (does not reach more than 90% of its volume)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: primary breast approach	Procedure: implant exchange operation; To perform implant exchange via axillary incision.
Experimental: axillary approach	Procedure: implant exchange operation; To perform implant exchange via axillary incision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Wound healing within 7 days post-operation	Without one of the following conditions：wound dehiscence requiring local wound care or operative intervention, wound infection requiring antibiotics 24hours post-operation, or debridement, within 7 days of post-operation.	up to 7 days post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
other surgical complications	Including hematoma, seroma, nipple and areola Necrosis, implant exposure, implant removal, and cyst contracture, measured by Clavien-Dindo stage.	one year
Breast Q score	The satisfaction of breast reconstruction of participants will be measured by Breast Q questionnaire 12 months post-operation. Breast-Q questionnaire is based on 6 dimensions: Physical health, mental health, sexual health, satisfaction with breast, satisfaction with surgical outcome, and satisfaction with medical care. The scores of each dimension are expressed as independent scores between 0 and 100 calculated by the Q Score system.	one year
Length of incision	length of incision measured within one-week post-operation.	up to 7 days post-operation
Pathological evaluation	A piece of scar tissue will be collected during surgery and embedded with paraffin, and pathological evaluation, including Masson staining, immune histochemistry of desmin, SMA, Ki67，TGFβ，Smad2/3，CTGF/CCN2，IL-6, IL-8，MMP-1，MMP-2，MMP-3，MMP-13，COL I，COLIII, COL-5. And the staining intensity will be measured by two independent pathologists.	through study completion

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Affiliated Hangzhou First People's Hospital, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB-2022- 1451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Anyone needs individual participant data should contact the main investigator via e-mail.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No